NCT00081653

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 719 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

• Post-Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 3 years
DRUG	ibandronate [Bonviva/Boniva]	100mg po monthly for 3 years

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-11-01
• Completion: 2008-05-01
• First posted: 2004-04-21
• Last updated: 2017-07-14
• Results posted: 2009-07-21

Locations

31 sites across 14 countries: United States, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, Spain, United Kingdom